The purpose of this research study is to investigate whether breast density measured by a safe, painless imaging method (called Diffuse Optical Spectroscopic Imaging - DOSI) can detect the decrease of breast density in subjects who receive tamoxifen when compared to patients who do not receive any drug. If decreased density can be reliably detected, it may help determine which subjects will benefit by taking tamoxifen or other chemoprevention drugs.

The goal of this study is to develop a safe, painless imaging method to measure the change in breast density caused by hormonal chemotherapy treatments such as tamoxifen. For many patients with breast cancer, chemoprevention drugs (such as tamoxifen) can reduce the risk of recurrence. However, tamoxifen can also cause serious side effects such as blood clots and an increased risk of uterine cancer. Patients would benefit from an individualized method of determining whether the chemoprevention is working. Recent studies have shown that a course of tamoxifen is more effective at reducing risk in women who exhibit >10% reduction in breast density compared to women who had little or no density change. The study suggests that breast density is a predictor of the effectiveness of tamoxifen. We propose to use an imaging method that uses safe visible and near-infrared light to measure breast tissue called diffuse optical spectroscopic imaging. Diffuse optical spectroscopic imaging allows patients to be followed through treatment with a cost-effective, bedside, handheld scanning probe. In this study, we will examine whether diffuse optical spectroscopic imaging is sensitive to the density changes induced by tamoxifen as a preventative hormonal chemotherapy agent. MRI will be used as the standard for comparison. We expect to discover that after 12-18 months, women on tamoxifen treatment will show a significant reduction in breast density compared to women not taking tamoxifen, and this change can be monitored using DOSI alone. If validated, our method could be used to determine if tamoxifen treatment is working in an individual patient and could guide doctors about the decision to end and/or switch to a different treatment. In addition, a validated index of density that can be obtained using an inexpensive, risk-free bedside technology could be applied to the challenging problem of measuring individual risk of breast cancer in the broader population.

Eligibility

Ages Eligible for Study:

21 Years to 50 Years

Genders Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Sampling Method:

Non-Probability Sample

Study Population

Two groups of subjects will be recruited:

Pre-menopausal women who will receive the chemoprevention drug tamoxifen (treated)

Pre-menopausal women who will not receive any chemoprevention drug (control)

Criteria

Treatment Group Inclusion Requirements

Premenopausal or peri-menopausal female older than 21 years of age

Elect to undergo, but have not yet started tamoxifen therapy;

Not pregnant and willing to use adequate contraception for the duration of study participation; and

Willing to avoid oral contraception use (which is not recommended while on tamoxifen treatment) for the duration of the study participation.

Normal Group Inclusion Requirements

Premenopausal or peri-menopausal female older than 21 years of age

Not pregnant and willing to use adequate contraception for the duration of study participation;

Exclusion (both groups) Requirements

Had or plan to receive any chemotherapy;

Have bilateral breast cancer

Previous treatment (chemotherapy, radiation, or surgery) to both breasts, including hormone therapy;

Have engaged in occupations or activities which may cause accidental lodging of ferromagnetic materials, or have imbedded metal fragments from military activities;

Have received orthodontic work involving ferromagnetic materials;

Are claustrophobic; or

Medically unstable.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01773551